BENTELAN ® Betamethasone

BENTELAN ® a drug based on Betamethasone.

THERAPEUTIC GROUP: Non-associated corticosteroids

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications BENTELAN ® Betamethasone

BENTELAN ® is indicated in the treatment of all those pathologies for which corticosteroid therapy is required such as bronchial asthma, allergies, inflammatory dermatoses, chronic inflammatory diseases such as rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis and neoplastic diseases affecting lymph tissue.

Mechanism of action BENTELAN ® Betamethasone

Betamethasone present in BENTELAN ® is a synthetic corticosteroid that can be taken orally, using effervescent tablets that make its administration simpler and more pharmacokinetically advantageous.

In fact, the maximum blood betamethasone peak is observed only 2 hours after BENTELAN ® oral intake and gradually decreases in the following 24 hours, thanks to a hepatic metabolism.

Linked to plasma proteins such as transcortin, betamethasone reaches target tissues and cells, permeating the cell membrane and binding nuclear receptors, capable of acting on DNA by modulating gene expression in favor of anti-inflammatory activity.

This activity, which represents the therapeutic property for which corticosteroids are used, is performed through the synthesis of a protein known as lipocortin, which is able to prevent the formation of arachidonic acid and pro-inflammatory mediators by inhibiting the enzyme phospholipase derivatives such as prostaglandins, prostacyclines and leukotrienes, thereby inhibiting the processes of recall and activation of the inflammatory cellular component and of various platelet and vascular modifications.

Although derived from hydrocortisone, betamethasone has a very low mineralocorticoid activity in spite of the particularly marked glucorticoid activity, which is manifested by the increase in glycaemia through the gluconeogenic pathway, by hepatic glycogenosynthesis and lipogenesis, particularly concentrated in the upper parts of the body like the face.

This and other biological properties limit the use of corticosteroids to serious pathologies for which therapy with non-steroidal anti-inflammatory drugs is not sufficient to shut down the reactive process.

Studies carried out and clinical efficacy

1. BETAMETASONE IN THE TREATMENT OF ALLERGIC RHINITIS

Study demonstrating the effectiveness of betamethasone at 1 mg / day for limited periods of time (5 - 7 days) in reducing the symptoms of allergic rhinitis, characterized by nasal obstruction and malaise. The therapy was effective both with and without the addition of antihistamines.

2. BETAMETASONE IN NEUROLOGICAL DISORDERS

Italian study demonstrating how low-dose betamethasone may be effective in improving neurological symptoms in patients with ataxia-telangiectasia, a progressive and untreatable neurodegenerative disorder.

3. TREATMENT WITH CORTICOSTEROIDS AND OSTEOPOROSIS

Example study showing how prolonged treatment of bronchial asthma with corticosteroids can increase the risk of osteoporosis in patients undergoing therapy. Predisposing factors such as smoking, sex, age and duration of treatment seem to play an important role in the progression of the disease.

Method of use and dosage

BENTELAN ® effervescent tablets of 0.5 - 1 mg of betamethasone:

the dosage should be formulated by the doctor after a careful evaluation of the physio-pathological state of the patient and his clinical picture.

Usually in short-term therapy and in the attack phase of long-term therapy, the dosage of betamethasone varies between 2 and 3 mg per day, while in the maintenance phase the dosage fluctuates between 0.5 - 1 mg daily.

The formulation in effervescent tablets, makes the taking of this medicine quite comfortable.

Warnings BENTELAN ® Betamethasone

The important biological characteristics of betamethasone expose patients subjected to drug therapy to particular risks.

Therefore it is important to consider the proper precautions before using this medicine to minimize the risk of serious side effects.

It is therefore necessary to rely on medical personnel both before and during the entire therapeutic protocol.

Patients with liver disease, inadequately treated latent infections and congestive heart failure should take BENTELAN ® with particular caution and under close medical supervision.

Furthermore the hyperglycaemic and calcium excretion of betamethasone could worsen the clinical picture of diabetic and osteoporotic patients .

The potential neurological symptoms such as headache, dizziness and anxiety described following the use of BENTELAN ® could make the use of machinery and driving vehicles dangerous.

PREGNANCY AND BREASTFEEDING

At the moment the data regarding the use of betamethasone in pregnancy are contradictory, given the potential alterations of the hormonal framework related to the intake of this active ingredient.

Consequently the administration of BENTELAN ® in pregnancy or during the lactation period should be carried out only in case of real need and under strict medical supervision.

Interactions

The betamethasone contained in BENTELAN ® can dramatically modify the therapeutic and biological effects of different active ingredients, determining for example an increase in the hypokalemia induced by amphotericin B, thiazide diuretics and furosemide, antagonizing instead the therapeutic action of oral anticoagulants, anticholinesterases, NSAIDs and contrast media.

In contrast, the pharmacokinetic and therapeutic properties of betamethasone can be altered by the concomitant intake of estrogens, barbiturates, phenytoin, ephedrine and rifampicin.

The metabolic effects of corticosteroids may also require an increase in the dosage of hypoglycemic agents in diabetic patients.

Contraindications BENTELAN ® Betamethasone

BENTELAN ® is contraindicated during systemic infections without adequate therapy or during various immunization procedures.

Betamethasone is also contraindicated in case of hypersensitivity to the active ingredient, of cutaneous and mucosal abrasions of various nature.

Undesirable effects - Side effects

Although betamethasone is structurally formulated to minimize the mineralocorticoid effect, long-term therapy with this hormone has been associated with various and widespread disorders:

Cardiovascular with the appearance of edema, hypertension and heart failure;
Central with headache, dizziness, anxiety, euphoria, insomnia, personality changes and depressive syndromes;
Dermatological, characterized by acne, rash, hives, hypertrichosis, dermatitis etc;
Endocrine with the appearance of amenorrhea, adreno-cortical insufficiency, disturbances in growth and alterations of the hypothalamic hypophyseal axis;
Gastrointestinal, marked by vomiting, diarrhea, ulcer, constipation and abdominal pain;
Muscular and skeletal with the presence of arthropathy, osteoporosis, bone fragility, myalgia, hypotrophy and tendon and joint damage;
Ocular with the appearance of cataracts and ocular hypertension;
Nutritional-metabolic with a significant increase in glycemic concentrations in the face of a negativization of the nitrogen balance.